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Life Sciences Firms Rejoice Over Patent Ruling

A U.S. court decision to toss out proposed U.S. Patent and Trademark Office rules limiting the size of patent applications was met with collective relief last week from the life sciences industry.

A ruling issued April 1 was a major victory for drug giant GlaxoSmithKline, which had challenged the proposed rules, and for local drug firms worried about complying with the restrictions.

In a 26-page opinion, U.S. District Court for the Eastern District of Virginia Judge James Cacheris granted GlaxoSmithKline’s motions for summary judgment, finding the patent office’s proposed limitations to the number of continuation applications and claims per patent to be improper extensions of its authority.

The office sought to limit patent application claims, which identify the scope of the legal pr otection that an invention should receive, to 25. It also proposed reducing the number of continuations to three.

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Continuations are especially important in the life sciences field because they allow applicants who have received a final rejection letter to continue arguing a case.

Currently, applicants have an unlimited number of claims and continuations.

“Quite simply, the result would’ve been huge administrative and cost burdens on patent holders as well as patent rights,” said Pedro Suarez, an intellectual property attorney in the San Diego office of Mintz, Levin, Cohn, Ferris, Glovsky and Popeo.

GlaxoSmithKline argued that the rules imposed by the patent office would stifle innovation. The world’s second largest pharmaceutical company also claimed the new rules would harm roughly 100 of its pending applications.


Injunction Granted

The company initially filed suit Oct. 9, and Judge Cacheris granted its request for a preliminary injunction Oct. 31, a day before the rules were to take effect.

“I think one of the basic issues we were having was that it does go against the intent of the patent system to reward people for new inventions and this was, to an extent, taking away that right,” said Lisa Haile, an intellectual property attorney in the San Diego offices of DLA Piper.

The patent office had argued that the changes were needed to help alleviate its backlog of applications.

“We are disappointed with this court’s decision, which rejects our view that the USPTO has the authority to implement the proposed rules about claims and continuations,” the patent office said in a written statement. “The USPTO believes that these rules are consistent with existing statutes and will strengthen the U.S. patent system for all stakeholders.”

The patent office indicated last week that it would appeal the ruling. In the meantime, Congress is looking to pass its most significant patent reform legislation in 50 years, and a provision included in the U.S. House of Representatives version of the bill could give rule making authorities to the patent commissioner.

Attorneys Haile and Suarez said it is possible that the provision would directly overrule the recent decision.

Proposed legislation aims to convert the U.S. patent system into a “first-to-file” system, which would give priority to the earlier filed application for a claimed invention and align the system with the rest of the world.

The stakes are especially high for California, which claims the biggest number of patents awarded than any other state. California inventors won 22,888 patents in 2007, according to the patent office. Texas ranked a distant second with 6,316 patents.

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